MigraineNCT02243865
Chordate System Prophylactic Migraine Clinical Investigation
A study testing Chordate System S200 + CT100 (active treatment) in people with Migraine, run by Chordate Medical at 4 sites in Sweden.
Trial summary
The purpose of this pilot study is to evaluate the performance of the Chordate System, in terms of the prophylactic effect and tolerability of treatment in patients diagnosed with migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Chordate System S200 + CT100 (active treatment)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 4 sitesSweden
- Study dates
- Oct 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the Informed Consent Form (ICF).
- Male or female aged between 18 and 65 years
- Diagnosed as suffering from migraine with or without aura according to International Headache Society´s (IHS) classification (International Classification of Headache Disorders (ICHD), 3rd edition, beta version)
- Reported history of 3 to 8 migraine episodes per month during previous 2 months, confirmed during baseline
- Reported history of at least 48 hours of freedom from headache between migraine attacks, confirmed during baseline
- Onset of migraine headache occurred before age 50
- Reported history of migraine for more than one year
- Reported stable dose of prophylactic migraine medication(s), if any, during the two months prior to screening (visit 1), and willing and able to maintain stable dose(s) until the three months follow-up (visit 4)
Who cannot join
- Meeting the ICHD criteria for medication overuse
- Reported history of 15 or more headache days per month (i.e. headaches of any kind), confirmed during baseline
- Reported frequency of non-migraine headaches exceeding 6 days per month, confirmed during baseline
- Unable to distinguish between migraine headaches and other headache types
- Treatment with Botox received within 6 months of the screening visit, or between the screening and treatment visits
- Ongoing treatment with implanted stimulator or other implanted device in the head and/or neck region
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- Known pronounced anterior septal deviation, or other known relevant abnormality in the nasal cavity, including bacterial infection and wounds
- History of sinus surgery, transphenoidal surgery for pituitary or other lesions or cerebrospinal fluid (CSF) rhinorrhea
- Fitted with a pacemaker/defibrillator
- Previously treated with therapeutic radiation to the face (that could have influenced the nasal mucosa)
- Ongoing upper respiratory tract infection or a body temperature >38.5°C (at treatment), or malignancy in the nasal cavity
- History of regular nose bleeding (epistaxis), or concomitant condition that could cause excessive bleeding, including treatment with the anticoagulant Varan
- Head injury or open wound that contraindicates use of Chordate Headband
- Known allergy to polyvinylchloride, a material used in the Catheter, or medicinal liquid paraffin
- Concurrent condition or risk of non-compliance that, in the investigator's opinion, may affect the interpretation of performance or safety data or which otherwise contraindicates participation in a clinical investigation
- Any change in migraine prophylaxis the previous two months
- Pregnant women
- Participation in a clinical research study within three months of enrolment or planned participation at any time during this clinical investigation
- Employees of the study site or the sponsor directly involved with the conduct of the study, or immediate family members or any such individuals
- Headache or migraine episode within the 48 hours prior to the first treatment
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Stortorgets neurologmottagning
Helsingborg, 25220
Läkarcentrum Stångåblick
Linköping, 582 19
Neurolgy Clinic
Stockholm, 11433
Neurologmottagningen Vällingby sjukhus
Vällingby, 162 68
About this study
Official title: A Randomized, Placebo-controlled, Double-blind, Multi-center Clinical Investigation to Evaluate the Prophylactic Effect and Tolerability of Intranasal Kinetic Oscillation Stimulation (KOS) Using the Chordate System S200 in Migraine Patients
The purpose of this pilot study is to evaluate the performance of the Chordate System, in terms of the prophylactic effect and tolerability of treatment in patients diagnosed with migraine.
Read the detailed description
This was a prospective, interventional, randomized, placebo-controlled, double-blind, multi-center clinical investigation of a medical device system.
A pilot study in which patients with frequent migraine attacks received intranasal KOS or placebo using the Chordate System S200 on two occasions.
- Conditions
- Migraine
- Being tested
- Chordate System S200 + CT100 (active treatment), Chordate System S200 + CT100 (placebo treatment)
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chordate System S200 + CT100 (active treatment)Device
Chordate S200 + CT100 (active treatment) gives Kinetic Oscillation Stimulation for 15 minutes to each nostril and by that giving an effect on the autonomic nervous system (ANS).
Chordate System S200 + CT100 (placebo treatment)Device
Chordate S200 + CT100 (placebo) is used in the same way as Active treatment, but no Kinetic Oscillation Stimulation is given. Catheter is not inflated and no vibration is given.
| Study group | Role | What they receive |
|---|---|---|
| Chordate S200 + control module (CT100), active | Experimental | Chordate System S200 giving Kinetic Oscillation Stimulation Treatment for 15 minutes in each nostril Receives: Device: Chordate System S200 + CT100 (active treatment) |
| Chordate S200 + control module (CT100), placebo | Placebo comparator | Chordate System S200 giving Kinetic Oscillation Stimulation in placebo mode. Non-inflated and non-vibrating treatment Receives: Device: Chordate System S200 + CT100 (placebo treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Number of Migraine Days Per Four Weeks During the Three Months Post Treatment Investigation Duration
A diary was used where patients added information each day on experienced migraine (yes/no). Baseline was defined as any migraine days from Day -29 until Day -1, i.e. the day before first treatment (Day 1). If full time period for baseline or the post treatment period was not documented, number of migraine days was recalculated with the formula:
Number of migraine days = (Number of migraine days x 28) / Number of days observed
If data was missing for any patient for more than 14 days during any period of interest, that patient was excluded from analysis.
The change from baseline in number of migraine days was calculated as follows:
Change = number of migraine days per four weeks for the 3 months post treatment period - number of migraine days per four weeks of the baseline period
As the difference between the post treatment period and baseline is presented, negative numbers indicate a post treatment decrease in number of migraine days.
Measured: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
Secondary outcomes (8)
Change From Baseline in Number of Migraine Days During the 1st, 2nd and 3rd Month and During the Final Four Weeks of the Three Month Post Treatment Investigation Duration
A diary was used where patients added information each day on experienced migraine (yes/no). Baseline was defined as any migraine days from Day -29 until Day -1, i.e. the day before first treatment (Day 1). If the full time period for either baseline or post treatment period was not documented number of migraine days was recalculated with the formula:
Number of migraine days = (Number of migraine days x 28) / Number of days observed
If data was missing for any patient for more than 14 days during any period of interest, that patient was excluded from the analysis of that time period.
The change from baseline in number of migraine days was calculated as follows:
Change = number of migraine days per four weeks for applicable post treatment period - number of migraine days per four weeks of the baseline period
As the difference between applicable post treatment period and baseline is presented, negative numbers indicate a post treatment decrease in number of migraine days.
Measured: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
Responder Rate
"Responder" defined as a patient with 50% or greater decrease in the number of migraine days per four weeks, for the 1st, 2nd and 3rd month post treatment vs baseline
Measured: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
A diary was used where patients added information on the maximum pain intensity on each day according to a 4-point categorical scale (none, mild, medium, severe).
The maximum documented pain intensity for each patient during each post treatment time period was tabulated for the active treatment and placebo groups.
Measured: From baseline (day ≥ - 28 days) to visit 4 (day 98, ± 7 days)
Mean Change From Baseline in Median Migraine Duration (Hours/Day) During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
A diary was used where patients added information each day on the number of hours with migraine. The median migraine duration in hours per day was determined for each patient, for each post treatment time period. Baseline for each patient was defined as the median number of migraine hours/day from Day -29 until Day -1, i.e. the day before the first treatment (Day 1).
The change in median migraine hours/day from baseline, for each defined post treatment time period, was then determined and the mean change is presented.
As the differences between applicable post treatment period and baseline is presented, negative numbers indicate a post treatment decrease in number of migraine hours/day.
Measured: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
Change From Baseline in Drug Consumption for Acute Treatment During the Three Month Post Treatment Investigation Duration
Measured: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI)
Patient satisfaction, evaluated by a clinician, was measured using 8-point clinical global impression (CGI) scores on an improvement scale (CGI-I: compared to condition at baseline, how much has changed: 0 = Not assessed, 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse).
Measured: At visit 4 day 98, ± 7 days
Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration
Number of Participants with a Change in Disease-specific Quality of Life, as measured by EQ-5D-3L, from Baseline (day 0, visit 2 before first treatment) to End of the Three Month Investigation Duration. EQ-5D-3L uses 5 categorical dimensions - motility, self-care, usual activities, pain/discomfort and anxiety/depression, each classified as improved, no change or worsened.
Measured: From baseline (day 0, visit 2) to visit 4 (day 98, ± 7 days)
Disease-specific Quality of Life (VAS Pain Scale) From Baseline to End of the Three Month Study Duration
Disease-specific quality of life, as measured by EQ-VAS, at baseline (day 0, visit 2 before first treatment) and at end of the three month study duration after treatment. The EQ VAS is a standard vertical 20 cm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a score from 0-100, where a higher score indicates greater pain intensity.
Measured: From baseline (day 0, visit 2) to visit 4 (day 98, ± 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chordate Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan-Åke Åkesson, MD, Study chair, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243865
- Sponsor's protocol ID
- PM005
- Status last verified
- Oct 2021
- First submitted
- 10 Sep 2014
- Last updated
- 8 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind, Multi-center Clinical Investigation to Evaluate the Prophylactic Effect and Tolerability of Intranasal Kinetic Oscillation Stimulation (KOS) Using the Chordate System S200 in Migraine Patients
- ClinicalTrials.gov ID
- NCT02243865
- Acronym / sponsor ID
- PM005
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Chordate MedicalIndustry (pharma, biotech, devices)
- Study start
- Oct 2014 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Sep 2014 (estimated)
- Results
- Posted 8 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to evaluate the performance of the Chordate System, in terms of the prophylactic effect and tolerability of treatment in patients diagnosed with migraine.
Detailed description
This was a prospective, interventional, randomized, placebo-controlled, double-blind, multi-center clinical investigation of a medical device system.
A pilot study in which patients with frequent migraine attacks received intranasal KOS or placebo using the Chordate System S200 on two occasions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chordate S200 + control module (CT100), active | Experimental | Device: Chordate System S200 + CT100 (active treatment)Chordate System S200 giving Kinetic Oscillation Stimulation Treatment for 15 minutes in each nostril |
| Chordate S200 + control module (CT100), placebo | Placebo comparator | Device: Chordate System S200 + CT100 (placebo treatment)Chordate System S200 giving Kinetic Oscillation Stimulation in placebo mode. Non-inflated and non-vibrating treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the Informed Consent Form (ICF).
- Male or female aged between 18 and 65 years
- Diagnosed as suffering from migraine with or without aura according to International Headache Society´s (IHS) classification (International Classification of Headache Disorders (ICHD), 3rd edition, beta version)
- Reported history of 3 to 8 migraine episodes per month during previous 2 months, confirmed during baseline
- Reported history of at least 48 hours of freedom from headache between migraine attacks, confirmed during baseline
Key exclusion criteria (20 listed)
- Meeting the ICHD criteria for medication overuse
- Reported history of 15 or more headache days per month (i.e. headaches of any kind), confirmed during baseline
- Reported frequency of non-migraine headaches exceeding 6 days per month, confirmed during baseline
- Unable to distinguish between migraine headaches and other headache types
- Treatment with Botox received within 6 months of the screening visit, or between the screening and treatment visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chordate System S200 + CT100 (active treatment)Chordate S200 + CT100 (active treatment) gives Kinetic Oscillation Stimulation for 15 minutes to each nostril and by that giving an effect on the autonomic nervous system (ANS). | Device | Chordate S200 + control module (CT100), active |
| Chordate System S200 + CT100 (placebo treatment)Chordate S200 + CT100 (placebo) is used in the same way as Active treatment, but no Kinetic Oscillation Stimulation is given. Catheter is not inflated and no vibration is given. | Device | Chordate S200 + control module (CT100), placebo |
Primary outcome
Change From Baseline in Number of Migraine Days Per Four Weeks During the Three Months Post Treatment Investigation Duration
Time frame: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
A diary was used where patients added information each day on experienced migraine (yes/no). Baseline was defined as any migraine days from Day -29 until Day -1, i.e. the day before first treatment (Day 1). If full time period for baseline or the post treatment period was not documented, number of migraine days was recalculated with the formula: Number of migraine days = (Number of migraine days x 28) / Number of days observed If data was missing for any patient for more than 14 days during any period of interest, that patient was excluded from analysis. The change from baseline in number of migraine days was calculated as follows: Change = number of migraine days per four weeks for the 3 months post treatment period - number of migraine days per four weeks of the baseline period As the difference between the post treatment period and baseline is presented, negative numbers indicate a post treatment decrease in number of migraine days.
8 secondary outcomes
Change From Baseline in Number of Migraine Days During the 1st, 2nd and 3rd Month and During the Final Four Weeks of the Three Month Post Treatment Investigation Duration
Time frame: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
Responder Rate
Time frame: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
Maximum Migraine Pain Intensity During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
Time frame: From baseline (day ≥ - 28 days) to visit 4 (day 98, ± 7 days)
Mean Change From Baseline in Median Migraine Duration (Hours/Day) During the 1st, 2nd and 3rd Month, the Final 4 Weeks and the Complete Three Month Post Treatment Investigation Duration
Time frame: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
Change From Baseline in Drug Consumption for Acute Treatment During the Three Month Post Treatment Investigation Duration
Time frame: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)
Patient's Satisfaction as Measured on Clinical Global Impression Scales (CGI)
Time frame: At visit 4 day 98, ± 7 days
Number of Participants With a Change in Disease-specific Quality of Life From Baseline to End of the Three Month Investigation Duration
Time frame: From baseline (day 0, visit 2) to visit 4 (day 98, ± 7 days)
Disease-specific Quality of Life (VAS Pain Scale) From Baseline to End of the Three Month Study Duration
Time frame: From baseline (day 0, visit 2) to visit 4 (day 98, ± 7 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan-Åke Åkesson, MD study chair
Linkoeping University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chordate System S200 + CT100 (active treatment) in people with Migraine, run by Chordate Medical at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Number of Migraine Days Per Four Weeks During the Three Months Post Treatment Investigation Duration (time frame: From baseline (28 days pre-treatment) to visit 4 (day 98, ± 7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.